36244 Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices

participating in the selection process to

consult with the others in selecting a

single member representing industry

interests for the panel within 60 days

after receipt of the letter. If no

individual is selected within 60 days,

the agency will select the nonvoting

member representing industry interests.

This notice is issued under the

Federal Advisory Committee Act (5

U.S.C. app. 2) and 21 CFR part 14,

relating to advisory committees.

Dated: June 26, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–17601 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Request for Nominations for Voting

Members on Public Advisory Panels or

Committees

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

nominations for voting members to

serve on certain device panels of the

Medical Devices Advisory Committee,

the Device Good Manufacturing Practice

Advisory Committee, and the Technical

Electronic Product Radiation Safety

Standards Committee in the Center for

Devices and Radiological Health

(CDRH). Nominations will be accepted

for current vacancies and those that will

or may occur through June 30, 1999.

FDA has a special interest in ensuring

that women, minority groups, and

individuals with disabilities are

adequately represented on advisory

committees and, therefore, encourages

nominations of qualified candidates

from these groups.

DATES: Because scheduled vacancies

occur on various dates throughout each

year, no cutoff date is established for the

receipt of nominations. However, when

possible, nominations should be

received at least 6 months before the

date of scheduled vacancies for each

year, as indicated in this notice.

ADDRESSES: All nominations and

curricula vitae for the device panels

should be sent to Nancy J. Pluhowski,

Office of Device Evaluation (HFZ–400),

CDRH, Food and Drug Administration,

9200 Corporate Blvd., Rockville, MD

20850.

All nominations and curricula vitae

for health professionals, industry

representatives, and government

representatives for the Device Good

Manufacturing Practice Advisory

Committee should be sent to Sharon

Kalokerinos, CDRH (HFZ–300),

Food and Drug Administration,

2094 Gaither Rd., Rockville, MD

20850.

All nominations and curricula vitae

for government and industry

representatives for the Technical

Electronic Product Radiation Safety

Standards Committee should be

sent to Orhan Suleiman, CDRH

(HFZ–240), Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850.

All nominations and curricula vitae

for general public representatives

for the Device Good Manufacturing

Practice Advisory Committee and

the Technical Electronic Product

Radiation Safety Standards

Committee should be sent to

Annette Funn, Office of Consumer

Affairs (HFE–88), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Kathleen L. Walker, Center for Devices

and Radiological Health (HFZ–17), Food

and Drug Administration, 2098 Gaither

Rd., Rockville, MD 20850, 301–594–

1283, ext. 114.

SUPPLEMENTARY INFORMATION: FDA is

requesting nominations of voting

members for vacancies listed below.

1. Circulatory System Devices Panel:

Two vacancies occurring June 30, 1999;

interventional cardiologists,

electrophysiologists, invasive (vascular)

radiologists, vascular and cardiothoracic

surgeons, and cardiologists with special

interest in congestive heart failure.

2. Clinical Chemistry and Clinical

Toxicology Devices Panel: One vacancy

occurring February 28, 1999; doctors of

medicine or philosophy with experience

in clinical chemistry, clinical

toxicology, clinical pathology, clinical

laboratory medicine, or oncology.

3. Dental Products Panel: Three

vacancies immediately, one vacancy

occurring October 31, 1998; dentists

who have expertise in the areas of

lasers, endosseous implants,

temporomandibular joint implants,

dental materials and/or endodontics; or

experts in bone physiology relative to

the oral and maxillofacial area.

4. Ear, Nose, and Throat Devices

Panel: One vacancy occurring October

31, 1998; audiologists, otolaryngologists,

neurophysiologist, statisticians, or

electrical or biomedical engineers.

5. General Hospital and Personal Use

Devices Panel: Three vacancies

immediately, one vacancy occurring

December 31, 1998; internists,

pediatricians, neonatologists,

gerontologists, nurses, biomedical

engineers or microbiologists/infection

control practitioners or experts.

6. Hematology and Pathology Devices

Panel: Two vacancies occurring

February 28, 1999; cytopathologists and

histopathologists; hematologists (blood

banking, coagulation and hemostasis);

molecular biologists (nucleic acid

amplification techniques), and

hematopathologists (oncology).

7. Immunology Devices Panel: One

vacancy immediately, one vacancy

occurring February 28, 1999; persons

with experience in medical, surgical, or

clinical oncology, internal medicine,

clinical immunology, allergy, molecular

diagnostics, human genetics testing or

clinical laboratory medicine.

8. Microbiology Devices Panel: Three

vacancies immediately, one vacancy

occurring February 28, 1999; infectious

disease clinicians; clinical

microbiologists with expertise in

antimicrobial and antimycobacterial

susceptibility testing, chemotherapy and

in vitro diagnostic (IVD) applications;

clinical virologists with expertise in

clinical diagnosis and IVD assays;

clinical oncologists experienced with

antitumor resistance and susceptibility;

and molecular biologists.

9. Obstetrics and Gynecology Devices

Panel: Two vacancies occurring January

31, 1999; experts in reproductive

endocrinology, endoscopy,

electrosurgery, laser surgery, assisted

reproductive technologies, and

contraception; biostatisticians and

engineers with experience in obstetrics/

gynecology devices; urogynecologists;

experts in breast care; and experts in

gynecology in the older patient.

10. Orthopaedic and Rehabilitation

Devices Panel: Two vacancies occurring

August 31, 1998; orthopedic surgeons

experienced with prosthetic ligament

devices, joint implants, or spinal

instrumentation; physical therapists

experienced in spinal cord injuries,

neurophysiology, electrotherapy, and

joint biomechanics; rheumatologists; or

biomedical engineers.

11. Radiological Devices Panel: Two

vacancies occurring January 31, 1999;

physicians and scientists with expertise

in nuclear medicine, diagnostic or

therapeutic radiology, mammography,

thermography, transillumination,

hyperthermia cancer therapy, bone

densitometry, magnetic resonance,

computed tomography, or ultrasound.

12. Device Good Manufacturing

Practice Advisory Committee: Four

vacancies immediately, one government

representative, one health professional,

one industry representative, and one

general public representative; five
Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices 36245

vacancies occurring May 31, 1999; two

government representatives, one health

professional, one industry

representative, and one general public

representative.

13. Technical Electronic Product

Radiation Safety Standards Committee:

Five vacancies immediately, two

government representatives, one

industry representative, and two general

public representatives; five vacancies

occurring December 31, 1998, one

government representative, three

industry representatives, and one

general public representative.

Functions

Medical Devices Panels

The functions of the panels are to: (1)

Review and evaluate data on the safety

and effectiveness of marketed and

investigational devices and make

recommendations for their regulation;

(2) advise the Commissioner of Food

and Drugs regarding recommended

classification or reclassification of these

devices into one of three regulatory

categories; (3) advise on any possible

risks to health associated with the use

of devices; (4) advise on formulation of

product development protocols; (5)

review premarket approval applications

for medical devices; (6) review

guidelines and guidance documents; (7)

recommend exemption to certain

devices from the application of portions

of the Federal Food, Drug, and Cosmetic

Act (the act); (8) advise on the necessity

to ban a device; (9) respond to requests

from the agency to review and make

recommendations on specific issues or

problems concerning the safety and

effectiveness of devices; and (10) make

recommendations on the quality in the

design of clinical studies regarding the

safety and effectiveness of marketed and

investigational devices.

The Dental Products Panel also

functions at times as a dental drug

panel. The functions of the drug panel

are to: (1) Evaluate and recommend

whether various prescription drug

products should be changed to over-thecounter status; and (2) evaluate data and

make recommendations concerning the

approval of new dental drug products

for human use.

Device Good Manufacturing Practice

Advisory Committee

The functions of the committee are to

review proposed regulations for

promulgation regarding good

manufacturing practices governing the

methods used in, and the facilities and

controls used for manufacture,

packaging, storage, installation, and

servicing of devices, and make

recommendations regarding the

feasibility and reasonableness of those

proposed regulations. The committee

also reviews and makes

recommendations on proposed

guidelines developed to assist the

medical device industry in meeting the

good manufacturing practice

requirements, and provides advice with

regard to any petition submitted by a

manufacturer for an exemption or

variance from good manufacturing

practice regulations.

Section 520 of the act (21 U.S.C.

360(j)), as amended, provides that the

Device Good Manufacturing Practice

Advisory Committee shall be composed

of nine members as follows: Three of the

members shall be appointed from

persons who are officers or employees

of any Federal, State, or local

government, two shall be

representatives of interests of the device

manufacturing industry, two shall be

representatives of the interests of

physicians and other health

professionals, and two shall be

representatives of the interests of the

general public.

Technical Electronic Product Radiation

Safety Standards Committee

The function of the committee is to

provide advice and consultation on the

technical feasibility, reasonableness,

and practicability of performance

standards for electronic products to

control the emission of radiation from

such products. The committee may

recommend electronic product radiation

safety standards for consideration.

Section 534(f) of the act (21 U.S.C.

360kk(f)), as amended by the Safe

Medical Devices Act of 1990, provides

that the Technical Electronic Product

Radiation Safety Standards Committee

include five members from

governmental agencies, including State

or Federal Governments, five members

from the affected industries, and five

members from the general public, of

which at least one shall be a

representative of organized labor.

Qualifications

Medical Device Panels

Persons nominated for membership

on the panels shall have adequately

diversified experience appropriate to

the work of the panel in such fields as

clinical and administrative medicine,

engineering, biological and physical

sciences, statistics, and other related

professions. The nature of specialized

training and experience necessary to

qualify the nominee as an expert

suitable for appointment may include

experience in medical practice,

teaching, and/or research relevant to the

field of activity of the panel. The

particular needs at this time for each

panel are shown above. The term of

office is up to 4 years, depending on the

appointment date.

Device Good Manufacturing Practice

Advisory Committee

Persons nominated for membership as

a government representative or health

professional should have knowledge of

or expertise in any one or more of the

following areas: Quality assurance

concerning the design, manufacture,

and use of medical devices. To be

eligible for selection as a representative

of the general public or industry,

nominees should possess appropriate

qualifications to understand and

contribute to the committee’s work. The

particular needs are shown above. The

term of office is up to 4 years,

depending on the appointment date.

Technical Electronic Product Radiation

Safety Standards Committee

Persons nominated must be

technically qualified by training and

experience in one or more fields of

science or engineering applicable to

electronic product radiation safety. The

particular needs are shown above. The

term of office is up to 4 years,

depending on the appointment date.

Nomination Procedures

Any interested person may nominate

one or more qualified persons for

membership on one or more of the

advisory panels or advisory committees.

Self-nominations are also accepted.

Nominations shall include a complete

curriculum vitae of each nominee,

current business address and telephone

number, and shall state that the

nominee is aware of the nomination, is

willing to serve as a member, and

appears to have no conflict of interest

that would preclude membership. FDA

will ask the potential candidates to

provide detailed information concerning

such matters as financial holdings,

employment, and research grants and/or

contracts to permit evaluation of

possible sources of conflict of interest.

Consumer/General Public

Representatives

Any interested person may nominate

one or more qualified persons as a

member of a particular advisory

committee or panel to represent

consumer interests as identified in this

notice. To be eligible for selection, the

applicant’s experience and/or education

will be evaluated against Federal civil

service criteria for the position to which

the person will be appointed.
36246 Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices

Selection of members representing

consumer interests is conducted

through procedures which include use

of a consortium of consumer

organizations which has the

responsibility for recommending

candidates for the agency’s selection.

Candidates should possess appropriate

qualifications to understand and

contribute to the committee’s work.

Nominations shall include a complete

curriculum vitae of each nominee and

shall state the the nominee is aware of

the nomination, is willing to serve as a

member, and appears to have no conflict

of interest that would preclude

membership. FDA will ask the potential

candidates to provide detailed

information concerning such matters as

financial holdings, employment, and

research grants and/or contracts to

permit evaluation of possible sources of

conflict of interest. The nomination

should state whether the nominee is

interested only in a particular advisory

committee or in any advisory

committee. The term of office is up to

4 years, depending on the appointment

date.

This notice is issued under the

Federal Advisory Committee Act (5

U.S.C. app. 2) and 21 CFR part 14

relating to advisory committees.

Dated: June 26, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–17603 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 92F–0443]

Dow Corning Corp.; Filing of Food

Additive Petition; Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

filing notice for a food additive petition

filed by Dow Corning Corp. to indicate

that the petitioner has also proposed

that the food additive regulations be

amended to provide for the safe use of

tetramethyltetravinylcyclotetrasiloxane

as an optional polymerization inhibitor

in the manufacture of

dimethylpolysiloxane coatings

produced by cross-linking a vinylcontaining dimethylpolysiloxane with

methylhydrogen-containing

polysiloxane and

dimethylmethylhydrogen polysiloxane

polymers using a platinum catalyst.

FOR FURTHER INFORMATION CONTACT:

Julius Smith, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3091.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

February 12, 1993 (58 FR 8290), FDA

announced that a petition (FAP 3B4346)

had been filed by Dow Corning Corp.,

P.O. Box 994, Midland, MI 48686–0994,

proposing to amend § 175.300 Resinous

and polymeric coatings (21 CFR

175.300), § 175.320 Resinous and

polymeric coatings for polyolefin films

(21 CFR 175.320), and § 176.170

Components of paper and paperboard

in contact with aqueous and fatty foods

(21 CFR 176.170) to provide for the safe

use of dimethylpolysiloxane coatings

produced by cross-linking a vinylcontaining dimethylpolysiloxane with

methylhydrogen-containing

polysiloxane and

dimethylmethylhydrogen polysiloxane

polymers using a platinum catalyst. The

petition also proposed that the food

additive regulations be amended to

provide for the safe use of 3,5-dimethyl1-hexyne-3-ol, 1-ethynylcyclohexene,

bis(methoxymethyl)ethyl maleate and

methylvinyl cyclosiloxane as optional

polymerization inhibitors. Additionally,

the petition proposed that the

regulations be amended to provide for

the safe use of 5-chloro-2-methyl-4-

isothiazolin-3-one and 2-methyl-4-

isothiazolin-3-one mixture, optionally

containing magnesium nitrate, as an

antimicrobial agent for emulsion-based

silicone coating formulations.

Subsequent to publication of the filing

notice, the petitioner amended the

petition to request the use of

tetramethyltetravinylcyclotetrasiloxane

as an optional polymerization inhibitor

in the manufacture of

dimethylpolysiloxane coatings

produced by cross-linking a vinylcontaining dimethylpolysiloxane with

methylhydrogen-containing

polysiloxane and

dimethylmethylhydrogen polysiloxane

polymers using a platinum catalyst.

Therefore, FDA is amending the filing

notice of February 12, 1993, to indicate

that the petitioner requests that the food

additive regulations be amended to

provide for the safe use of

tetramethyltetravinylcyclotetrasiloxane

as an optional polymerization inhibitor

in the manufacture of

dimethylpolysiloxane coatings

produced by cross-linking a vinylcontaining dimethylpolysiloxane with

methylhydrogen-containing

polysiloxane and

dimethylmethylhydrogen polysiloxane

polymers using a platinum catalyst.

The agency has determined under 21

CFR 25.32(i) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Dated: June 11, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–17548 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0484]

Eastman Chemical Co.; Filing of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Eastman Chemical Co. has filed a

petition proposing that the food additive

regulations be amended to provide for

the safe use of di-2-

ethylhexylterephthalate as a component

of closure- sealing gaskets for food

containers.

FOR FURTHER INFORMATION CONTACT:

Hortense S. Macon, Center for Food

Safety and Applied Nutrition (HFS–

205), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3086.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 8B4593) has been filed by

Eastman Chemical Co., P.O. Box 431,

Kingsport, TN 37662. The petition

proposes to amend the food additive

regulations in § 177.1210 Closures with

sealing gaskets for food containers (21

CFR 177.1210) to provide for the safe

use of di-2-ethylhexyl terephthalate as a

component of closure-sealing gaskets for

food containers.

The agency has determined under 21

CFR 25.32(i) that this action is of the

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment